FDA Registration
Active
🇩🇪 Germany
TAMINA 3.5mm Proximal Humerus Plates
Reg #: 3004638532
·
FEI: 3004638532
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PURACON GMBH
- Registration Number
- 3004638532
- FEI Number
- 3004638532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Isarstrasse 1
- City
- Rosenheim Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K213864
Owner / Operator
- Firm Name
- puracon GmbH
- Operator Number
- 10028435
- Address
- Isarstrasse 1
- City
- Rosenheim
- State
- Bavaria
- Postal Code
- D-83026
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-10-20 |
Proprietary Names
TAMINA 3.5mm Proximal Humerus Plates
LEPORELLO 3.5mm Olecranon Plates
Variable Angle Locking Screws
POYA 3.5mm Lateral Proximal Tibia Plates
CASCELLA 3.5mm Superior Clavicle Plates
SALGINA 2.5mm Volar Distal Radius Plates
DALVAZZA 2.5mm Distal Ulna Plate
Cortical screws
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)